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Clinical Pharmacology & Central lab

Linking Truth Technology Co., Ltd. (LTT) is committed to becoming the first-class clinical pharmacology CRO in China and worldwide, to provide end-to-end full service development model for the highest quality for new drugs.

The service scope covers clinical pharmacology support throughout entire life cycle of drug development, bioanalysis of large molecules, and Phase I Unit platform collaboration.

Transition from Non-clinical to Clinical Stage

  • Develop overall Clinical Pharmacology strategy for new medicinal entities (NMEs)
  • Predict pharmacokinetic/pharmacodynamic (PK/PD) characteristics of NMEs for first-in-human (FIH) studies, develop FIH protocol

Early Phase of Clinical Development (Phase I)

  • Develop/update overall Clinical Pharmacology strategy for NMEs, support of traditional Clinical Pharmacology studies
  • Expertise in using population modeling/simulation approach to facilitate critical decision making for NMEs (eg, Phase II dose selection)
  • Bioanalysis of biologics (large molecules): PK/biomarkers/ADA; assay method development

Late Phase of Clinical Development (Phase II/III)

  • Update the overall Clinical Pharmacology strategy for NMEs
  • Quantitative pharmacological analysis support (eg, Pop-PK/PD, E-R, Phase III dose selection, dose recommendation for special populations)

Drug Registration Stage and Training Service

  • Support NDA package preparation: Clinical Pharmacology related summaries, draft label
  • Registration related consultation: Pre-IND and Pre-NDA meetings
  • Provide Clinical Pharmacology training service to Phase I Units and Pharmaceutical companies

Central Lab Service

LTT’s central lab is located in Fengtai Science and Technology Park, Beijing, equipped with international first-class instruments and high quality management system. This lab provides bioanalysis of large molecules, including therapeutic monoclonal antibodies, bispecific antibodies, modified proteins, fusion proteins, therapeutic polypeptides, antibody-drug conjugates (ADC), hormone drugs, cytokines, vaccines, gene therapy products and nucleic acids, etc.

Please contact us for additional information on how our Quality Assurance team can help improve the quality of your clinical studies.

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